Comparison of two upper airway devices with endotracheal tube in individuals undergoing laparoscopic surgeries
- Registration Number
- CTRI/2019/01/016929
- Lead Sponsor
- Bhagat Phool Singh Government Medical College For Women
- Brief Summary
Till date, tracheal intubationis considered to be the gold standard for providing seal in laparoscopicsurgeries but over a period of time supraglottic airway devices ( like I-gel and Proseal Laryngeal Mask Airway) haveevolved which overcome the disadvantages of endotracheal tube.A comparison ofI-gel, Proseal Laryngeal Mask Airway and Endotracheal Tube in laparoscopicsurgeries by Rukhsana Najeeb et al in 2015 shows that I-gel was easier toinsert with higher success rate in first attempt (92.5%) than Proseal LaryngealMask Airway (85%) and endotracheal tube (82.5%).(3) Tilldate, there are limited studies which have evaluated and compared I-gel,Proseal Laryngeal Mask Airway and Endotracheal tube together for features like leakvolume, leak fraction and leak pressure. Wewill conduct this study to compare supraglottic airway devices like I-gelTMand Proseal Laryngeal Mask Airway with standard endotracheal tube for theparameters that include number of attempts taken for insertion, hemodynamicchanges, ventilation parameters, leak volume, leak fraction, leak pressure andpostoperative complications during general anaesthesia, in healthy adultpatients undergoing laparoscopic surgeries. First 90 patients meeting the inclusion criteria will be enrolled in thestudy. Group E (n=30) receivingendotracheal tube, Group P (n=30) receiving Proseal Laryngeal Mask Airway andGroup I (n=30) receiving I-gel for airway maintenance. Patients will beassessed for insertion characteristics of airway devices (insertion at firstattempt with no resistance; insertion at second attempt; insertion at thirdattempt and failed insertion - insertion not possible), hemodynamic responses(heart rate and blood pressure), ventilation parameters, leak pressure, leakvolume, intraoperative and postoperative complications. Statistically significant(p<0.05) increase in heart rate and the mean blood pressure will be observedimmediately after insertion, persisted till 5 minutes after intubation andduring the time of extubation. We will observe incidence of blood staining ofthe device, sore throat and dysphasia,coughing, laryngospasm, gastric insufflation, regurgitation, aspiration, billous secretion, stridor, hoarseness of voice, injuries (to lip, teeth, and gum), and dysphonia during perioperativeperiod.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
Patients who have the ability to give informed consent (i) Age: 18-65 years (ii) ASA I–II (iii) elective surgery (iv) fasting for at least 8 hours.
Patients with ASA physical Status III or IV, anticipated difficult airway, mouth opening <2.5 cm, cervical spine disease ,obesity (body mass index > 35 kg/m 2 ), oropharyngeal pathology, emergency cases, cardiopulmonary disease, cervical spine fracture or instability, or at increased risk of aspiration (gastro-esophageal reflux disease, hiatus hernia, full stomach and heartburn), pregnant patients, reported history of any pathology of the neck or airway, history of lung diseases or oesophageal reflux will be excluded.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the efficacy ease and insertion characteristics of supraglottic airway devices & endotracheal tube 120 min
- Secondary Outcome Measures
Name Time Method To determine the hemodynamic changes and ventilation parameters and intraoperative and postoperative laryngo-pharyngeal morbidity and sealing pressure 24 hours
Trial Locations
- Locations (1)
Bhagat Phool Singh Government Medical College For Women
🇮🇳Sonipat, HARYANA, India
Bhagat Phool Singh Government Medical College For Women🇮🇳Sonipat, HARYANA, IndiaPranshi JainPrincipal investigator7056090969jainpranshi25@gmail.com